Tuesday, March 18, 2008

Single or Multiple-Use Medical Instruments?

Today's Wall Streeet Journalrejuvenates a long-standing debate in hospitals: that of re-cycling equipment that is labeled "single use" to save on costs. Re-sterilization of instruments has become a multi-million dollar industry. Why? Because what hospitals care about most these days is saving money on consumables, and what better way to save than to recycle an instrument for a small fee and charge the patient for a new single-use instrument.

In effect, this is done every day in hospitals that reprocess instruments.

Now to be fair, what really happens from the hospitals' perspective is they get a lump sum reimbursement payment for a procedure and must use that amount to pay for all of the procedural consumables, including instruments. That lump sum payment amount is negotiated with the insurer well before any talk of re-using instruments occurs. It is usually negotiated assuming new "single-use" instruments are used. Further, because reprocessing has been "approved" by the FDA for some instruments under careful regulation, it's legit and hospitals can save a bundle.

Although rare, legal precedent has been established where re-used catheters were found dangerous. Was this a frivolous case or were there circumstances that were less than ideal? At least one jury thought their might have been a problem.

Cases like this sent shock waves around local hospitals - at least for a time.

But money is a strong motivator. Equipment and staff aren't getting cheaper. So to reassure hospitals, the re-sterilization industry began offering liability coverage as a form of indemnity against potential legal challenges regarding the safety of their service. Also, they point to the FDA which has sanctioned their process as "safe."

So naturally, many hospitals have entered back into the fold of re-use.

The instrument manufacturing industry is now understandably incensed and outraged at these reprocessors because the practice of instrument re-use substantially cuts into their bottom line profits. In my estimation, manufacturers sell about one tenth of their usual instruments to hospitals, since it is not uncommon for a "single-use" non-metallic instruments to be reprocessed 8 to 10 times before being discarded. Some metallic instruments may be used far longer.

Meanwhile, patients do not see the savings - the hospitals pass this on to cover other expenses. C'est la vie.

But the manufacturers have one thing on their side: the patient safety argument. You can never be too safe these days.

The manufacturers can point to ethylene oxide (used to sterilize instruments that cannot withstand heat) that can be harmful to humans, and there have been instances where excessive levels were detected on re-processed electrophysiology catheters when screened. For the clinician, there's no readily-apparent way to detect for residual ethylene oxide contaminants before procedures at the patient's bedside, so we take it in trust that levels are satisfactorily low. Were the instruments allowed to "air" for 14 days? Impossible to tell - we have to rely on those handy-dandy FDA inspections to assure compliance. Or alternatively, there have been small studies that found proteinacious material on catheters after re-sterilization. Eeeewwww.

So to combat the large preprocessing industry, device manufacturers wanted patient's to consent to the use of re-sterilized and re-used equipment during their surgeries. Seems reasonable, right?

But this hasn't happened.

Imagine.

Now to be fair, I have been on both sides of this debate - I have worked at institutions that have re-sterilized instruments and I have worked at institutions that are single-use. I found that doctors are shoved into this debate unwittingly: we need the hospital to do our procedures and provide the instruments, but may not like having to use re-processed instruments on our patients. In the case of electrophysiology catheters - they just don't handle the same. Further, the thought that a patient is unaware of this practice is unsettling. Because of the nature of medicine these days, we assume the responsibility for the patient's well-being in tandem with the hospital. Yet often, we are not part of the discussion regarding the use of preprocessed instruments. If we are, then the whole murky area of what it took for doctors to agree to using these re-used catheters begins to raise its ugly head.

So while economic arguments exist on both sides of the device re-reprocessing fence, we must not lose sight that it's the patient that matters here. Certainly, if re-used instruments are being used in a laboratory, I believe that patients should be made aware and have this included in their informed consent, with any potential risks spelled out. Further, if a patient knew they could apply some of the cost savings of re-processing toward their procedure costs, then perhaps they'd be more willing to agree to the practice.

But the subterranean way things happen now is not acceptable.

Given the current satate of affairs, here's the ultimate litmus test on this issue in my book:

If you were having a procedure, which instrument(s) would you want used on yourself: re-processed or single-use?

11 comments:

Jay sent the web address to me the other day. I have enjoyed reading your comments - particularly the hall of fame series.

On the reprocessing issue, isn't the question not the reprocessing itself, but are the reprocessed instruments actually sterile? If they are, and hospitals receive a fixed payment for the procedure but can reduce operating costs - isn't that legitimate? Whether the funds are applied to other operating or capital expenses isn't germane. Most hospital margins are slim, with a significant portion of unreimbursed indigent care. I do agree with your point on full disclosure of the process to the patient in advance.

Boy, I can see both sides of this argument. But as a doctor, we are often asked to "weigh in" on such issues that are inherently in conflict with our primary obligation: our patients. It is true that re-sterilization has been found to be generally safe. But there are fatigue issues with instruments (particularly cardiac and radiologic catheters) that are not routinely tested. I find it ironic that the FDA requires as "single use" label, yet permits re-processing. Does "re-processing" assess tensile strength of catheters? No. It only deals with re-sterilization (which I agree they do fairly well). It's a tough situation, especially if the doctor is employed by the hospital system urging re-use - will he jeopardize his employment if he disagrees to the practice?

I guess I'm asking for a compromise to leave the patient as the ultimate arbiter of this debate - the challenge will be the age old question they might ask if they agree to the re-use of equipment: "what's in it for me?"

Hmmm...It's not up on foxnews.com right now, but on the day of your post, your were listed along the right side as one of the best health blogs. It's apparently powered by blogburst. Anyhoo, I was like, hey!!! I read that blog!

If I were your doctor and was asked, I'd answer that there is no substantive evidence that multiuse catheters cause harm. There are even precious few anecdotes out there, and for every anecdote about a harmful reused device, I can counter with an anecdote about a harmful new device.

The reuse "debate" is driven by the special interests of the catheter companies. They just can't seem to let this one go. Every couple of years, the same petty arguments get trotted out. Despite being on the radar screen for years, there never seems to be a smoking gun. That should tell us all something. Find me a reputable clinician who is not on the payroll of the catheter industry who will join this debate in earnest. Highly reputable institutions such as my own have resterilized for years without issues. We (EP lab at Christ Hospital, Cincinnati) were even profiled in Washington Post about this topic in a front page article from 2005.

The author was going for some type of expose. No Pulitzer Prize, unfortunately.

The "informed consent" argument only applies if there is actually a risk to the action carried out. I would suggest that the risk of harm from power failures, computer crashes and earthquakes during the case are demonstrably higher that the risk or certified reprocessed devices. Do you include in your informed consent these risks? Does your patient know the status of your hospital's backup generator or the the age of your recording system's hard drive? Maybe you should put this on the consent too. How about adding in the amount of sleep the MD got the night before?

Let's be realistic here and hold off on this one-sided debate so clearly driven by industry.

Jay

P.S. If you want to do an ablation on me, feel free to use reprocessed catheters if you would like. I trust you.

The FDA would likely never approve a catheter that was labeled for more than a single use. I just happen to be sitting in front of a project plan for a new catheter-based imaging device. It includes three months of biocompatability tests, including three tests for cytotoxicity, sensitization, heomolysis, three types of hemocompatibility and some others. Following this is two months of sterilization testing, including three weeks for ETO residuals. How does one test this for repeat use?

I believe that many (though not all) devices can be safely reprocessed. Just as the evidence against reprocessing is scant, so is there a fundamental lack of well structured, prospective evidence that can be used to determine which devices can and can not be safely reused.

Informed consent is absolutely key. For my ablation, kindly use a pristine device.

I've been approaching this issue from a different angle. I'm leading development of a device (not a cardiac device), and we could very well have made a portion of it reusable (after cleaning and sterilization), and doing so might have made it both less expensive for hospitals and more profitable for us... but after some research we figured there was no way it would sell due to an inherent preference for disposable single-use devices.

So my opinion is that there are definitely some devices that could be made reusable, and that could save everyone a lot of money without compromising safety. But obviously there needs to be some way to verify any claims that reuse of such a device is safe.

This one seems to be dying out, but let me make one last (long) point.

The only real requirement to require a catheter to be single use is a label that the catheter company says it it single use. Industry labels a device single use, because they need us MDs to use more of their device to improve their profits to their bottom line. As our previous poster added also above, it would cost more money to get multi-use labeling because of the testing involved.

No wonder why these devices are labeled single use.

Recall, however, that the reprocessing companies are regulated by the FDA and reprocessed catheters meet rigorous testing requirements. The reprocessing companies also wish to protect their profits and shareholders.

It is my job, as a physician, to see through all this crap and do what is right for my patient. No doubt, patient safety is paramount. Any doctor, however, that fails to take into account the cost of the care he or she delivers, shares a good chunk of the blame for spiraling health care costs. That goes for the patients who blindly insist on getting "only the best" as well. As far as I'm concerned, those individuals should forfeit their right to complain about rising health care premiums and declining MD reimbursement.

An EP catheter is not a sophisticated instrument that cannot hold up to multiple uses. There is no objective evidence to the contrary. These have been used this way for years. The reprocessed catheters are tested for reliability. If a catheter doesn't work well, we take it out and get a new one. This happened to me today with two NEW catheters today.

"Any doctor, however, that fails to take into account the cost of the care he or she delivers, shares a good chunk of the blame for spiraling health care costs. That goes for the patients who blindly insist on getting "only the best" as well. As far as I'm concerned, those individuals should forfeit their right to complain about rising health care premiums and declining MD reimbursement."

Jay, I am unaware of any of the cost-savings of catheter-reprocessing being trickled down to patients. In fact, my health care premium has risen steadily - no doubt yours too. Further, I have never seen a credit applied to my health care bills for this service. Instead, the funds pay for software upgrades for mapping systems, robotics and such which have not been shown to improve patient outcomes, but look cool (and patients love to see on the news since their medical center is "cutting edge.")

While I agree in concept with your comments, lets not fool ourselves that these "cost savings" are passed on to the patient directly except as providing for new technologies.

I recognize that any individual cost savings measures exercised by a patient or doctor may be hard to appreciate on a direct basis. If, however, we only take care of ourselves blind to the entire health care system, we are part of the problem, not part of the solution.

Imagine how much more money we all could spend as physicians if we didn't care about cost. How about MRI for all headaches? Celebrex instead of Ibuprofen for all achy knees? I could go on. Depending upon the insurance status of the individual patient, the increased costs for these poor habits may not be felt at all by the patient.

Consumption of health care resources is a zero sum game. If you spend money today, it's got to come out of someone's pocket. Eventually that will come back to you. There are a lot of reasons that health care premiums are rising, but most we can't control. Any responsible physician should do what he or she can to control what little part of the system that they can. Every decision to spend money should be considered in a cost effectiveness context (recognizing of course, that patient safety and good medical care trumps all other considerations).

In our hospital, a good chunk of our cost savings are used to support indigent care, AEDs in schools, and donations to the AHA. If the hospital runs in the red, you can bet these would go away.

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.